BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2896265 · Received December 5, 2012

    Report

    Report Number
    1720753-2012-10152
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 11, 2012
    Report Date
    December 5, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND RESEATED CIRCUIT BOARDS AND CONNECTORS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PERFORMING FLUOROSCOPY, THE MONITOR BECAME BLACK AND THE KV VALUE TRACKED TO MAX. THE FIELD ENGINEER NOTED THAT IT WAS THE LEFT MONITOR THAT WENT BLACK, CAUSING A LOSS OF THE LIVE IMAGE AND THUS MAKING THE SYSTEM UNUSABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1